Agency classClass IIIOur severity:Low FDA (Drugs)·D-1137-2015·Announced 2015-06-24

Novartis Recalls Foradil Aerolizer Due to Failed Stability Testing

Novartis is recalling Foradil Aerolizer inhalation powder because it failed a particle size distribution stability test. The recall covers 19,658 packs distributed in New Jersey.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a failed stability specification rather than a direct safety hazard like contamination or mislabeling.

Plain-English summary

Novartis Pharmaceuticals Corp. is recalling Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule. The recall involves 19,658 packs, specifically Lot F8011 with an expiration date of May 2015. The product was distributed in New Jersey via one distributor.

The recall was initiated because the product failed a stability specification. Specifically, an out-of-specification result was obtained for the Particle Size Distribution test during stability testing. This is an FDA Class III recall, which indicates that the product is not likely to cause adverse health consequences.

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for a replacement or refund. The product is manufactured for Merck Sharp & Dohme Corp. and manufactured by Novartis Pharma AG.

The recalled product

Product: Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 12 Capsules (Blister strips of 6) per pack. For inhalation use only, Rx only, Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of MERCK & CO., INC. Whitehouse Station, NJ 08889. Manufactured…
Manufacturer: Novartis Pharmaceuticals Corp.
Category: Drug — Inhalation Powder
Hazard: stability-failure
Affected units: 19,658

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Lot #: F8011
Exp May 2015

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Novartis Pharmaceuticals Corp. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · Novartis Pharmaceuticals Corp.

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Same hazard · stability failure